Real‐world data of a digitally enabled, time‐restricted eating weight management program in public sector workers living with overweight and obesity in the United Kingdom: A service evaluation of the Roczen program

Abstract Introduction The health of the United Kingdom workforce is key; approximately 186 million days are lost to sickness each year. Obesity and type 2 diabetes (T2D) remain major global health challenges. The aim of this retrospective service evaluation was to assess the impact of a digitally enabled, time‐restricted eating (TRE) intervention (Roczen Program, Reset Health Ltd) on weight and other health‐related outcomes. Methods This service evaluation was conducted in people living with overweight/obesity, with 89% referred from public sector employers. Participants were placed on a TRE, low‐carbohydrate, moderate protein plan delivered by clinicians and mentors with regular follow up, dietary guidance, goal setting, feedback, and social support. Results A total of 660 members enrolled and retention was 41% at 12 months. The majority were female (73.2%), 58.9% were of White ethnicity, with a mean (SD) age of 47.5 years (10.1), and a body mass index of 35.0 kg/m2 (5.7). Data were available for 82 members at 12‐month. At 12‐month, members mean actual and percentage weight loss was −9.0 kg (7.0; p < 0.001) and −9.2% (6.7, p < 0.001) respectively and waist circumference reduced by −10.3 cm (10.7 p < 0.001), with 45.1% of members achieving ≥10% weight loss. Glycated hemoglobin was significantly improved at 6 months in people living with T2D (−11 mmol/mol [5.7] p = 0.012). Binge eating score significantly reduced (−4.4 [7.0] p = 0.006), despite cognitive restraint increasing (0.37 [0.6] p = 0.006). Conclusion Our service evaluation showed that the Roczen program led to clinically meaningful improvements in body weight, health‐related outcomes and eating behaviors that were sustained at 12‐month.


| INTRODUCTION
Workplace health is essential, especially within public services such as healthcare and transport, where staffing levels affect service delivery and public safety.Unemployment is associated with an increased risk of cardiovascular disease, poorer mental health, and early death. 1 The estimated cost of sickness absence and worklessness in the United Kingdom (UK) is over £100 billion per year, which is greater than the annual cost of running the National Health Service (NHS). 2 Data shows that in the UK, in 2022, 185.6 million workdays were lost to sickness absence, with a record high of 104.9 million of these days lost to those living with long term conditions. 3People living with obesity have been shown to have an additional four extra absence days per year. 4NHS workforce data showed sickness absence was over 2.4 million workdays in March 2022. 5Staff absences are higher amongst clinically qualified staff, including ambulance workers, doctors and nurses, with mental health, musculoskeletal issues and cardiovascular disease being reported as key reasons. 5Well-being and stress also predict sick leave and productivity level. 6Furthermore, obesity is linked to 2-3 times higher levels of extended work absence 7 and is associated with mental health and musculoskeletal conditions. 8This has resulted in both the government and employers introducing workplace health interventions to improve the health of the workforce.Despite this, there remain challenges in maintaining workplace health.
Obesity and type 2 diabetes (T2D) are significant global public health concerns, 9 with data showing that 44% of public sector workers are living with overweight or obesity. 10Interventions proven to help manage both conditions include lifestyle intervention, pharmacotherapy and bariatric and metabolic surgery. 11However, access to services for treatment in the UK remains limited, with only 60% of regions in England having access to Specialist Obesity services (Tier 3), 12 resulting in potential health inequalities based on postcode. 13gital health tools are increasingly used to assist patients in chronic disease self-management, and form an integral part of the NHS long-term plan. 14These have been shown to improve health behaviors, increase compliance with treatment 15 and may improve access to healthcare. 16These interventions may also be applicable to address workers' health, with digitally delivered occupational health interventions shown to improve worker well-being and reduce metabolic risks. 17,18Therefore, digital health interventions may offer a novel solution to improve healthcare access and improve the health of the public sector workers.

Continuous energy restriction can help people lose weight;
however, there is significant variability in response and more recently time-restricted eating (TRE) has increased in popularity. 19TRE is a form of intermittent fasting involving a period of fasting and eating within each 24-h period for example, 16:8 (16 h fasting and 8 h eating). 20Substantial evidence exists supporting the effectiveness of TRE in achieving substantial weight loss, cardiometabolic health, and mental health. 21,22Despite this, there remains limited evidence evaluating a digital TRE program in patients living with overweight and obesity, particularly in the real world and in a workplace setting.This has considerable potential to lead to improvements in health and adherence to intervention and specialist healthcare access whilst offering a person-centered and personalized approach.Therefore, a retrospective service evaluation was conducted of the impact of the Roczen program on body weight (BW), surrogate markers of cardiovascular disease, and other-health related indices in people living with overweight and obesity.

| METHODS
A retrospective service evaluation was conducted to assess the impact of a digitally enabled TRE intervention (Roczen Program, Reset Health Ltd) on people living with overweight/obesity, the majority of whom enrolled, via self-referral, to an employer-led health incentive program.For those who enrolled via their employer, their place on the intervention was paid for (by the employer) for 12 months.Shift-workers were allowed to enroll.These individuals, upon confirmation of eligibility and onboarding, became members of the Roczen program.

| Roczen program
The Roczen Program is a medically-led, technology-enabled weight management program (https://www.roczen.com/).It has been designed by a multidisciplinary team of specialists to help people living with obesity and/or T2D and other complications to improve metabolic health, quality of life, and reduce associated disease risk.focus on engaging and empowering the patient in decisions that impact their health whilst highlighting the health consequences of chronic disease, practical behavioral instruction on realistic lifestyle changes, and the benefits of optimal obesity and diabetes management. 24,25Over the first 12 weeks, members were recommended to increase physical activity (PA) from their baseline and reduce sedentary behavior.All members were provided with videos detailing foundational movements.Ongoing PA was supported throughout the program with goal-setting and self-monitoring to add specific exercises or activities that the patient found acceptable and beneficial.

Members can use the
There was no specification on the type of PA prescribed as various forms of PA can benefit health. 26Prior to commencing the Roczen program, participants were assessed Binge Eating Disorder (BED) to ensure safety using the Binge Eating Scale (BES) and, if required, clinical interview. 27

| Member pathway
The member pathway is initiated with a self-referral and sign-up process where members who are eligible at this stage give consent for the medical team to access their NHS Summary Care Records.
The individual then gains access to the Roczen Mobile App, and the clinician is alerted to the prospective member in the web-based Roczen Clinic App.
The medical team arranges a video consultation and sends digital versions of validated health questionnaires to assess mental health, eating behaviors, the risk of sleep apnea and binge eating.If they remain eligible, members are onboarded in their first video consultation and assigned a peer-to-peer mentor.Together, the clinician and member agree on an initial 12-week plan.The timing of eating and fasting was tailored to the individual and based on patient preference, but members were encouraged to retain the same TRE pattern where feasible.They then received written materials with guidance on TRE, nutrition, and BCTs.Additionally, they are given personalized content for other relevant conditions or considerations which may impact progress, such as shift work or menopause.
Members were not advised to eat ad libitum, and instead were advised to eat two discrete meals with a break in between where snacking was discouraged.The most common TRE pattern was a fasting window between 8 and 12 PM the next day, constituting a 16 h fast, with the first meal between 12 and 2 PM and the second meal between 6 and 8 PM.Regardless of personal preference, all members were encouraged to finish eating before 8 PM.
All new members were facilitated to undergo an HbA1c blood test for the purpose of T2D screening, via a postal capillary blood testing kit.
Members have ongoing biometrics monitoring and follow-up facilitated via the Roczen app, through both asynchronous messaging and synchronous video consultations with clinicians. 28herence was assessed by clinicians during virtual clinical consultations.Some members volunteer to become mentors via an educational program provided by Roczen, others continue on the program to aid maintenance, and others leave by choice.Within the program, members were not advised to leave or be discharged by the clinical team at any set point, in keeping with the chronicity of obesity and T2D.For members with T2D treated with insulin, mentoring was provided by a clinician and monitoring requirements stipulated were more frequent, including weekly weights for the first 12 weeks rather than monthly as per the weight management pathway.Mentors were encouraged to continue their own program whilst providing dedicated peer-to-peer support to other members on the program, and were incentivized through a point-based reward system.

| Outcome measurement
The primary outcome was BW change at 12 months from baseline.

| Eligibility criteria for the program
To be eligible for the program, individuals had to be ≥18 years old with minimum body mass index (BMI) criteria defining overweight related to ethnicity specific cut-offs. 11Further screening was carried out to ensure members with exclusionary conditions such as type 1 diabetes, pregnancy, eating disorder diagnosis and suicidal ideation were not included for safety and increased risk (further details are supplied in Supporting Information S1).

| Data collection
Data were self-reported to clinicians during review appointments or via the Roczen app.Members were advised on how to accurately measure key outcomes such as weight, WC, or BP.Due to the COVID-19 pandemic, there were challenges obtaining anthropometric, BP, and other outcome data during this period.Baseline measurements for BW, BMI, WC, and BP were deemed acceptable �2 weeks of plan initiation.An HbA1c measurement was considered acceptable between −12 weeks and þ4 weeks following plan initiation.This timeframe was agreed on a pragmatic basis given the realworld nature of the service and its evaluation.Furthermore, HbA1c measurement was assessed in addition to a clinical consultation, noting possible symptoms or signs suggesting uncontrolled diabetes, which would prompt delayed onboarding or reassessment.
analysis this is not reflective of the retention rate but rather the available data at this time point for analysis.HbA1c outcomes are reported at 3 and 6 months only for people living with T2D based on the availability of data at the time of analysis.Note that as this was a rolling program, the available data at each time point does not signify the retention rate of the program but rather indicative of those members who had successfully submitted data within the acceptable time frames (Figure 1).

| Statistics analysis
Statistical analysis was performed on SPSS Statistics (IBM, Version 26.0) with all graphs being created using GraphPad Prism.Statistical significance was defined as a p-value <0•05.As this was a service evaluation, no formal sample size calculation was conducted.Demographic data were summarized using mean (standard [SD]) for parametric data and median (interquartile [IQR]) for non-parametric data.Continuous data with categorical data were summarized using counts (percentages).To assess the differences in pre-and postintervention, parametric and non-parametric data were analyzed using appropriate tests (t-test; paired t-tests; Mann Whitney-U test; Friedman) and one way Analysis of Variance was performed to see if T2D and prediabetes, sex, or living with obesity impacted on weight loss outcome.Appropriate log transformation was performed.Bonferroni adjustment was used for multiple comparisons. 33Binomial logistic regression was used to assess predictors of members completing the program with sex, ethnicity, age, baseline weight, PHQ-9 and TFEQ sub-scales were used as control variables.Odd ratios, 95% confidence intervals and p-values were reported for significant outcomes.The assumptions of each model were checked and met.

| Ethics
This was a retrospective service evaluation reviewing previously collected data from the Roczen member and therefore required no formal ethical approval.

| RESULTS
In total, 660 were eligible and enrolled with the Roczen program (Figure 1, Table 1).The reasons for members not enrolling were due to medically ineligible, individuals changed their mind, or not respond to initial invitation correspondence.Overall retention to the Roczen program was 41% at 12 months, with retention at 3, 6, and 9 months being 85%, 70% and 54%, respectively (Figure 1).
Outcome data were available for 82 members at 12 months.
Compared to the baseline, members significantly reduced BW and percentage BW by 9.0 kg (SD 7.0, p < 0.001) and 9.2% (6.7, p < 0.001) respectively, BMI by 3.3 kg/m 2 (SD 2.6; p < 0.001), and WC by 10.3 cm (SD 10.7; p < 0.001) equivalent to a 9.5% reduction (Table 2, Figure 2).Members also significantly reduced BW, BMI, and WC at 3, 6 and 9 months (Table S1).Further exploratory analysis assessed the impact of pre-diabetes and T2D, living with obesity and sex on percentage weight loss at 12 months, showing that neither living with obesity, prediabetes, nor T2D impacted on percentage weight loss (Table S2).Those living with obesity had greater percentage weight loss at 3 and 6 months compared with those living with overweight F I G U R E 1 Members data capture and retention rate at each time point over 12-month.n, number; %, percentage.
but not at 9 months (Table S3).Sex impacted percentage weight loss at 12-month with females losing more weight than males.However, no difference was seen at 3, 6 or 9 months (Table S4).
At 12-month, depression and anxiety scores showed no significant change (Table 2); however, differences were found at other time points over the 12-month.At 3-and 6-month depression score was significantly lower (z = −9.3,p < 0.001; z = −5.5, p < 0.001, respectively, Table S1) but there was no change at 9 months.Anxiety was significantly lower at all other time points relative to baseline (3 months z = −8.3;p < 0.001, 6 months z = −4.9p < 0.001; 9 months −2.6, p = 0.009, respectively, Table S1).Over the 12-month program, when compared to baseline, there were trends toward a higher proportion of members living with no depression (PHQ-9) or no anxiety (GAD-7), as well as a lower proportion of members with moderate to severe depression (PHQ-9) (Table S7).
When looking at eating behavior, binge eating score significantly reduced between baseline and 12 months (−4.4,SD 7.0, p = 0.006), as well as other time points relative to baseline (  S1).The restraint subscale of the TFEQ score was higher at 12 months (3.7,SD 6.4, p < 0.001), 3 and 6 months, but not at 9 months (Table S1).
After correction for multiple comparisons, there were no differences in baseline characteristics between those that had data available at 12-month and those that were enrolled in the program.
Furthermore, binomial logistic regression was used to assess the predictors of members completing the Roczen program and no predictors were identified from the baseline characteristics.

| DISCUSSION
This service evaluation of the Roczen program provides real-world evidence of a novel, digitally enabled TRE intervention leading to clinically meaningful improvements in body anthropometry, eating behavior, and mental health in overweight and obese patients.The majority of members (89%) were public service workers who selfreferred via staff wellbeing and occupational health program to help improve their health.From this service evaluation, the Roczen program appears to have health benefits in this population, 34 which could incur benefits to employers.
Interventions targeting the occupational health of a healthcare workforce are critical for potentially improving health, reducing absence rates and improving productivity.Digitally delivered occupational health interventions improve workers' health concerns and overall well-being and may reduce metabolic risk. 17,18Here, it is shown that the Roczen program leads to clinically significant and, importantly, sustainable weight loss at 12-month in public sector workers.Mean percentage weight loss was 9.2%, with over 76% of members reducing their weight by ≥5%. 35Notably, at 12 months nearly half of the members lost ≥10% weight loss, while 15.9% achieved a BW loss of ≥15%.A 5% reduction is classed as clinically significant BW loss; however, further reductions have been shown to have greater improvements in health.For instance, 5%-10% improves mobility, while ≥15% weight loss has been linked to T2D remission and improvements  in hepatic steatosis. 35Further evaluation is required to determine the direct of impact of the Roczen program on other important healthrelated outcomes including glycemic control, T2D remission, lipid profile, and liver health, as improvements may partly be driven by weight-independent mechanisms influenced by TRE. 20,36e Roczen program appears comparable to other NHS tier 2 and 3 weight management program.Recent data from Tier 2 and Tier 3 weight management services showed mean aggregated weight loss of 2.2-12.4kg, with 32%-51% of completers achieving ≥5% weight loss. 37Data from the digital stream of the NHS Diabetes Prevention Program revealed a mean weight reduction of 3.1 kg. 38Roczen is also comparable to other digitally delivered lifestyle interventions, where care is delivered by dietitians or health coaches via digital applications rather than clinicians. 39,40Our retention rates was comparable to those in other Tier 3 specialist obesity program, with drop out ranging from 10% to 78% at the end of follow-up. 41Overall, this service evaluation shows encouraging outcomes when compared to well established in-person and digitally delivered NHS program.
Twelve-month outcome data showed WC, an indicator of central adiposity, was reduced by >10 cm.Central adiposity is independently linked to an increased risk of T2D, non-alcoholic fatty liver disease (NAFLD) and early death. 42,43Although we did not define NAFLD at baseline or liver function within the service evaluation, there is a likelihood that the improvements in body anthropometry may be of benefit and incur potential improvements in glycemic control. 44-7 of 10 In members living with T2D, glycemic control was significantly improved at 3 and 6 months, by approximately 10 mmol/mol equivalent to 1%.Despite this being in a relatively small subset of the membership, these show promising results regarding the impact of the Roczen program on glycemic control.Furthermore, members with T2D reduced weight by nearly 10% at 12 months (Table S2), which is clinically significant, not least because weight loss in those with T2D is usually inferior to those with prediabetes or normoglycaemia. 45[48] Although changes in glycemic control at 12 months were not formally reported due to challenges in obtaining data during COVID- 19, there is considerable potential for concomitant impact on glycemic control and BW in patients with T2D. 35rthermore, of interest, females at 12-month lose relatively greater amounts of BW compared with men.It is unclear as to the reason for this difference at this time-it may relate to greater data capture of women at 12-month but may also reflect that TRE as a dietary method is an effective method for weight in females more than in men.Further evaluation is warranted.
Our data demonstrate that the Roczen program effectively reduces systolic and diastolic BP in the short term up to 9 months, but these effects were not maintained at 12-month despite the reductions being similar.This likely reflects the smaller number of members and intra-variability of BP readings at 12 months.Although the changes in BP were relatively small, ranging between approximately 3-5 mmHg, reductions of 5 mmHg in SBP have been suggested to reduce the risk of major cardiovascular events by 10%. 49At a population level, a 3 mmHg change in SBP has been suggested to prevent or postpone 11,000 coronary heart disease deaths over 7 years, 50 showing that even relatively small reductions in BP can have substantial cardiometabolic benefits.Notably, previous research has highlighted that 3 months of TRE in people with the metabolic syndrome leads to improved cardiometabolic health parameters. 51e Roczen program applies multiple evidence-based BCTs, including goal setting paired with self-monitoring, feedback, motivational interviewing, and peer-to-peer social support. 39It can be hypothesized that these BCTs may underpin the improvements in mental health and weight loss maintenance in those completing 12month.Furthermore, remote but empathic social engagement, as afforded through the novel mentoring aspect of the Roczen program, likely drive improvements. 52ople living with obesity and T2D have an increased risk of poorer mental health, including depression and anxiety. 53,54Importantly, the members showed small though significant improvements in depression and anxiety symptoms at periods throughout the program.
While program members tended toward low levels of depression and anxiety at baseline, there were a clinically significant number at baseline reporting either moderate to severe depression or anxiety, respectively.At 12-month, no member appeared to report either severe or moderately severe depression, potentially showing improvement in those with the poorest mental health.
There remains concern that engaging in fasting and restrictive diets may increase the development of disordered eating, specifically BED. 55An important finding from this service evaluation was that binge eating scores did not deteriorate and in fact improved over the 12-month program.This would show the idea that eating disorder risk is not impacted within behavioral weight management interventions offered alongside healthcare support, and that such clinically supervised program may in fact may be of benefit. 56r service evaluation has several strengths.Firstly, a large proportion of the members were public service workers, with this representing a novel intervention in this population and offering a novel and deliverable intervention to improve workplace health for this population.Secondly, the Roczen program which is a medically led, digital TRE program featuring peer-support mentoring, showed the feasibility of delivery and clinical efficacy of this approach.Finally, our data show the program's potential efficacy across a diverse population including a variety of ethnic groups.
Our service evaluation has limitations.Despite the large sample size that enrolled, there were challenges in obtaining self-reported data at standardized time points from members, resulting in missing data.This meant that a pragmatic approach needed to be used to gather sufficient data; therefore, as described in the methodology plus and minus 2 weeks was used for outcome data and 12 weeks for HbA1c.However, this is not just a problem with our service evaluation, with over half of the participants in the NHSE digital DPP program missing weight data at 6 months 57 Nevertheless, having adjusted for missing weight data, the weight loss remained clinical and statistically significant and appears comparable, if not greater, to other digital program offered by the NHS. 38

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Roczen Mobile App to message the clinical team at any time and are followed up every 4-week by a clinician via telephone or video consultation.The program is unique as it offers mentoring for peer-led social support via the App and regular feedback is provided to the members through varied modalities of clinical interactions.The program utilizes TRE alongside low-carbohydrate and moderate protein intake (see Supporting Information S1 for more detail on mentor scheme and program development).Energy intake monitoring and measurement of macronutrient composition are not specified to members.The program incorporates additional evidencebased behavior change techniques (BCTs), including goal setting paired with self-monitoring, motivational interviewing, habit formation, incentivized mentor scheme, and educational resources. 23These 2 BROWN ET AL.

T A B L E 2
Summary of results of available data for 82 participants: Key outcomes at 12 months.